BEUDAMED
    FDA Recall Terminated

    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.

    Recall: Z-2803-2017 · Initiated June 22, 2017

    Recall

    Recall Number
    Z-2803-2017
    Event Number
    77640
    Firm
    Quidel Corporation
    FEI Number
    2024674
    Product Code
    PFQ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 22, 2017
    Terminated
    June 7, 2019
    Address
    10165 McKellar Ct, San Diego, CA, 92121-4201

    Description

    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.

    Reason

    In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.

    Action

    Quidel sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected customers. The notice instructed consignees to check inventory for affected lots (11705359 and 1705405), to remove and destroy any affected sample collectors from affected kits, and complete and return the attached Inventory Assessment/Certificate of Destruction form to Quidel by fax at 858-552-7905 or email to [email protected]. Any questions by consignees should be directed to Quidel's Technical Support Team at 800-874-1517 or 858-552-1100, or by email at [email protected]. It is requested that consignees keep recall notification and response in their records.

    Distribution

    Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, & WV.

    Quantity

    1078 kits, 21,560 sample collectors